Yuki Tahata1, Hayato Hikita1, Satoshi Mochida2, Norifumi Kawada3, Nobuyuki Enomoto4, Akio Ido5, Hitoshi Yoshiji6, Daiki Miki7, Yoichi Hiasa8, Yasuhiro Takikawa9, Ryotaro Sakamori1, Masayuki Kurosaki10, Hiroshi Yatsuhashi11, Ryosuke Tateishi12, Yoshiyuki Ueno13, Yoshito Itoh14, Taro Yamashita15, Tatsuya Kanto16, Goki Suda17, Yasunari Nakamoto18, Naoya Kato19, Yasuhiro Asahina20, Kentaro Matsuura21, Shuji Terai22, Kazuhiko Nakao23, Masahito Shimizu24, Taro Takami25, Norio Akuta26, Ryoko Yamada1, Takahiro Kodama1, Tomohide Tatsumi1, Tomomi Yamada27, Tetsuo Takehara28. 1. Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. 2. Department of Gastroenterology and Hepatology, Saitama Medical University, Saitama, Japan. 3. Department of Hepatology, Graduate School of Medicine, Osaka City University, Osaka, Japan. 4. First Department of Internal Medicine, Faculty of Medicine, University of Yamanashi, Yamanashi, Japan. 5. Digestive and Lifestyle Diseases, Department of Human and Environmental Sciences, Kagoshima University Graduate School of Medicine and Dental Sciences, Kagoshima, Japan. 6. Department of Gastroenterology, Nara Medical University, Nara, Japan. 7. Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. 8. Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime, Japan. 9. Division of Hepatology, Department of Internal Medicine, Iwate Medical University, Iwate, Japan. 10. Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan. 11. Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan. 12. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. 13. Department of Gastroenterology, Faculty of Medicine, Yamagata University, Yamagata, Japan. 14. Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan. 15. Department of General Medicine, Kanazawa University Hospital, Kanazawa, Japan. 16. The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Chiba, Japan. 17. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan. 18. Second Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan. 19. Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan. 20. Department of Gastroenterology and Hepatology, Department of Liver Disease Control, Tokyo Medical and Dental University, Tokyo, Japan. 21. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. 22. Division of Gastroenterology and Hepatology, Graduate School of Medicine and Dental Sciences, Niigata University, Niigata, Japan. 23. Department of Gastroenterology and Hepatology, Nagasaki University of Graduate School of Biomedical Sciences, Nagasaki, Japan. 24. Department of Gastroenterology/Internal Medicine, Gifu University Graduate School of Medicine, Gifu, Japan. 25. Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan. 26. Department of Hepatology, Toranomon Hospital, Tokyo, Japan. 27. Department of Medical Innovation, Osaka University Hospital, Suita, Osaka, Japan. 28. Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. takehara@gh.med.osaka-u.ac.jp.
Abstract
BACKGROUND: Real-world data on the efficacy and safety of sofosbuvir plus velpatasvir (SOF/VEL) treatment for patients with hepatitis C virus (HCV)-related decompensated cirrhosis are limited in Japan. METHODS: A total of 190 patients with compensated (108) or decompensated (82) cirrhosis who initiated direct-acting antiviral (DAA) treatment between February 2019 and August 2019 were enrolled. Sustained virologic response (SVR) was defined as undetectable serum HCV-RNA at 12 weeks after the end of treatment (EOT). RESULTS: The SVR12 rates were 92.6% in patients with compensated cirrhosis and 90.2% in patients with decompensated cirrhosis (p = 0.564), and the treatment completion rates were 98.1% and 96.3%, respectively (p = 0.372). In patients with decompensated cirrhosis, 3 patients discontinued treatment and 2 patients died because of liver-related events. In patients with decompensated cirrhosis with SVR12, 50% of patients with Child-Pugh class B at baseline showed improvement to class A at SVR12, and 27% and 9% of patients with Child-Pugh class C at baseline showed improvement to class B and class A at SVR12, respectively. Patients who achieved SVR12 showed elevated serum albumin levels at the EOT, which were further elevated at SVR12, but no elevated serum albumin levels after the EOT were observed in patients with baseline serum albumin levels less than 2.8 g/dl. CONCLUSIONS: Real-world efficacy of SOF/VEL treatment for patients with decompensated cirrhosis was similar to Japanese phase 3 study, although treatment discontinuation and death related to liver disease occurred. In patients with poor hepatic reserve, whether it improves continuously after viral clearance requires further evaluation.
BACKGROUND: Real-world data on the efficacy and safety of sofosbuvir plus velpatasvir (SOF/VEL) treatment for patients with hepatitis C virus (HCV)-related decompensated cirrhosis are limited in Japan. METHODS: A total of 190 patients with compensated (108) or decompensated (82) cirrhosis who initiated direct-acting antiviral (DAA) treatment between February 2019 and August 2019 were enrolled. Sustained virologic response (SVR) was defined as undetectable serum HCV-RNA at 12 weeks after the end of treatment (EOT). RESULTS: The SVR12 rates were 92.6% in patients with compensated cirrhosis and 90.2% in patients with decompensated cirrhosis (p = 0.564), and the treatment completion rates were 98.1% and 96.3%, respectively (p = 0.372). In patients with decompensated cirrhosis, 3 patients discontinued treatment and 2 patients died because of liver-related events. In patients with decompensated cirrhosis with SVR12, 50% of patients with Child-Pugh class B at baseline showed improvement to class A at SVR12, and 27% and 9% of patients with Child-Pugh class C at baseline showed improvement to class B and class A at SVR12, respectively. Patients who achieved SVR12 showed elevated serum albumin levels at the EOT, which were further elevated at SVR12, but no elevated serum albumin levels after the EOT were observed in patients with baseline serum albumin levels less than 2.8 g/dl. CONCLUSIONS: Real-world efficacy of SOF/VEL treatment for patients with decompensated cirrhosis was similar to Japanese phase 3 study, although treatment discontinuation and death related to liver disease occurred. In patients with poor hepatic reserve, whether it improves continuously after viral clearance requires further evaluation.
Authors: Mariana Sandoval Lourenço; Patricia Momoyo Y Zitelli; Marlone Cunha-Silva; Arthur Ivan N Oliveira; Roque Gabriel Rezende de Lima; Evandro de Oliveira Souza; Claudia P Oliveira; Tiago Sevá-Pereira; Flair J Carrilho; Mario G Pessoa; Daniel F Mazo Journal: Clinics (Sao Paulo) Date: 2021-11-19 Impact factor: 2.365